Results: A total of 11 patients were enrolled. And we could analyze the blood level in10 patients and the CSF level in 8 patients. Median patients-age was 66 years old. All patients were adenocarcinoma. In EGFR mutation status, 5 patients had exon 19 deletion, 3 had L858R and 3 had minor (exon18) mutation. The patients with PS 2 were 3 patients and PS 3 were 4 patients. Almost all patients received AFA after third-line or more line chemotherapy. The blood level was the Median 88.2 ng/ml (range: 30.4-373), the CSF level was Median 1.4 ng/ml (range: 0.39-2.85) and the CSF penetration rate was Median 1.65% (range: 0.1-9.25). The ORR is 27.3%, and two of three petients with exon 18 mutation showed the partial response. Median OS was 3.8 months (95%CI: 1.1-13.1) and median PFS was 2.0 months (95%CI: 0.6-5.8). Hematological toxicity was mild, however we have to take care of severe diarrhea and skin toxicities, especially in patients with poor PS.

Conclusion: The median CSF penetration rate (1.65%) of AFA were higher than the penetration rate in previous case report. Although the efficacy for EGFR mutation positive patients with LC was moderate, the promising efficacy for the patient with LC harboring EGFR exon 18 mutation was demonstrated. And we have to take care of diarrhea and skin toxicities, especially in the patients with poor PS.

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P3.02b-015 - Impact of Metastatic Status on the Prognosis of Patients Treated with First Generation EGFR-TKIs (ID 4243)

Background: First generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) such as gefitinib (GEF) or erlotinib (ERL) are effective for patients harboring EGFR mutations positive non-small cell lung cancer (NSCLC). To know the impact of metastatic status on patients treated with EGFR-TKIs is important. The objective of this study is to know the impact of metastatic status including brain metastasis, bone metastasis, liver metastasis and pleural effusion on the prognosis of patients treated with first generation EGFR-TKIs.

Methods: The pathology files of National Hospital Organization Kinki-chuo Chest Medical Center from 2009 to 2014 were retrospectively reviewed and 533 patients were EGFR mutation positive NSCLC. Patients with stage IA to IIIA and small cell lung cancer were excluded. From 299 stage IIIB, IV and relapsed NSCLC patients, 178 patients treated with GEF or ERL as first line treatment were enrolled for the study. Metastatic status, progression free survival (PFS), overall survival (OS) and response rate (RR) were investigated. We also evaluated the relationship between the number of metastatic organs and prognosis.

Conclusion: Bone metastasis had correlated with worse PFS and brain metastasis had correlated with worse OS in patients treated with first generation EGFR-TKIs. Moreover, the much number of metastasized organs was related to worse PFS and OS.

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Background: Cisplatin and pemetrexed with or without bevacizumab is the most effective treatment for advanced non-squamous NSCLC patients without EGFR mutations. On the other hand, erlotinib and bevacizumab is the most effective treatment for advanced non-small cell lung cancer (NSCLC) patients with activating epidermal growth factor receptor (EGFR) mutations. There have not been any evidence-based studies of erlotinib and bevacizumab in combination with platinum-doublet therapy for advanced non-squamous NSCLC patients with EGFR mutations, therefore we performed Quartet trial to determine the safety and efficacy of quartet chemotherapy with cisplatin plus pemetrexed with erlotinib and bevacizumab as a first-line treatment.

Methods: Patients received escalated doses of cisplatin plus pemetrexed with erlotinib and bevacizumab every 3 weeks for 4 cycles. We examine the dose limiting toxicity (DLT) to determine the maximum tolerated dose (MTD) and recomended dose (RD) of quartet chemotherapy.

Results: 10 patients were enrolled in Quartet trial. 3 patients were men and 7 patients were women. Median age was 69 (65-75) years old. 4 patients had exon19 mutation and 6 patients had exin21 mutation. Of a total of 10 patients, 8 patients received maintenance therapy without unexpected or cumulative toxicities. One of six patients experienced DLT (vagal reflex of grade3) at 60mg/m[2] cisplatin plus 500 mg/m[2 ]pemetrexed with 150mg erlotinib and 15mg/kg bevacizumab (RD). Four patients experienced no DLT, however one patient experienced severe toxicities (gastrointestinal hemorrhage of grade3) during 2 cycle of induction chemotherapy and dose reduction was needed at 75mg/m[2] cisplatin plus 500 mg/m[2 ]pemetrexed with 150mg erlotinib and 15mg/kg bevacizumab (MTD). In DLT phase, most frequent adverse events were nausea, anorexia and fatigue. In Quartet trial study, the overall response rate was 100%. Furthermore, progression free survival and overall survival were not reached.

Conclusion: This quartet chemotherapy was a tolerable and effective regimen, and we determined the combination of cisplatin at 60mg/m[2] plus 500 mg/m[2 ]pemetrexed with 150mg erlotinib and 15mg/kg bevacizumab was RD and the combination cisplatin at 75mg/m[2 ]was MTD in chemotherapy-naïve advanced non-squamous NSCLC patients harboring EGFR mutations (UMIN000012536).